QA/RA Lead for Medical Devices

RRD Company; Houston (TX); On-site; USD 107,000 - 171,000; Full time

Job summary

RRD is seeking a Manager of Quality Assurance and Regulatory Affairs to oversee the site Quality Management System and regulatory compliance for medical device and pharma manufacturing. The role leads a team of quality engineers, auditors, and specialists, ensuring effective CAPAs, root cause analysis, and product release governance across locations.

The position requires a Bachelor’s in a technical or life sciences field, 5+ years of leadership experience, and 3 years in medical device or

Qualifications

• Bachelor's degree in a technical or life sciences field.
• 5+ years of related work experience including team leadership.
• 3 years medical device or pharma QA or RA experience.

Responsibilities

• Lead the implementation and continual improvement of the site QMS and regulatory affairs.
• Manage team of quality engineers, supervisors, specialists and auditors.
• Lead product release for medical devices and advise on process validation strategies.

Skills

Quality leadership

Regulatory affairs

QMS implementation

Auditing

Quality risk management

Communication

Education

Bachelor's degree in technical or life sciences

Tools

eQMS systems

Microsoft Word

Microsoft Excel

Job description

RRD is seeking a Manager of Quality Assurance and Regulatory Affairs to oversee the site Quality Management System and regulatory compliance for medical device and pharma manufacturing. The role leads a team of quality engineers, auditors, and specialists, ensuring effective CAPAs, root cause analysis, and product release governance across locations.

The position requires a Bachelor’s in a technical or life sciences field, 5+ years of leadership experience, and 3 years in medical device or